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EMEUNET tailors EULAR experience for young rheumatologists
Young rheumatologists and researchers will find plenty of relevant content at this year’s EULAR Congress in Madrid, June 14-17, thanks to a dedicated presentation track. Other tailored opportunities include networking events, mentorship for first-time attendees to help them make the most of their EULAR experience, and a unique opportunity for small group discussion and networking with key opinion leaders in rheumatology in the so-called mentor-mentee meetings.
The Young Rheumatologists track provides three sessions with a special focus on researchers and clinicians who are early in their careers, Sofia Ramiro, MD, PhD, explained in an interview. Dr. Ramiro chairs the steering committee of the Emerging Eular Network (EMEUNET), a network of young clinicians and researchers in the field of rheumatology in Europe.
Another session will zero in on osteoarthritis, vasculitis, spondyloarthritis, and rheumatoid arthritis, with a shorter lecture format and more time left for a question-and-answer session and discussion. With a group of younger rheumatologists in attendance, “the sessions are somewhat more informal,” promoting a comfortable and interactive environment for discussion and learning, Dr. Ramiro said.
The third session in the Young Rheumatologists track will consist of case discussions focused on how to counsel and take care of women who have rheumatoid arthritis and would like to become pregnant. Two patient cases will be presented and discussed by leaders in the field. “Again, the idea is to make these presentations as real-world as possible,” Dr. Ramiro said.
The EMEUNET booth will be in the EULAR Village, and, for the first time, the booth will be incorporated in the EULAR booth, as a “pillar” under the bigger EULAR umbrella. Dr. Ramiro said to be sure to stay tuned for a surprise associated with EULAR’s 70th anniversary. On the evening of Thursday, June 15, EMEUNET will host a networking event.
On the morning of Friday, June 16, mentor-mentee meetings organized by EMEUNET link five to six young attendees with mentors, according to area of interest. Sign up is available online, allowing small group discussion with leaders in academic rheumatology. This year, meetings will be led by Iain McInnes, PhD (Glasgow, Scotland), Josef Smolen, MD (Vienna), and William Dixon, MBBS, PhD (Manchester, England). Mentorship topics can include the incorporation of research into a clinical career, general career advice, and insight into international collaboration, Dr. Ramiro said.
“These are usually very well-attended meetings and very popular,” she said. “People who have participated in them always give us very good feedback and are very enthusiastic about how easily accessible these very famous key opinion leaders are and what good advice they give to them.”
Finally, the Ambassador program helps first-time attendees get the most out of EULAR. “I think that we all know that the first time we attend such a huge conference the experience can be daunting,” Dr. Ramiro said. Now in its third year, the ambassador program pairs an EMEUNET member with up to six first-timers. The ambassador helps the newcomers decide which sessions to attend and remains available through mobile phone, social media, and the meeting app throughout the meeting.
All of EMEUNET’s activities during EULAR support the organization’s aim of “widening collaboration and fostering collaboration among young researchers and clinicians,” Dr. Ramiro said. “The ultimate aim is to improve and promote education in the area of our diseases and to foster research collaborations,” she said of the 1,500-member strong organization.
Young rheumatologists and researchers will find plenty of relevant content at this year’s EULAR Congress in Madrid, June 14-17, thanks to a dedicated presentation track. Other tailored opportunities include networking events, mentorship for first-time attendees to help them make the most of their EULAR experience, and a unique opportunity for small group discussion and networking with key opinion leaders in rheumatology in the so-called mentor-mentee meetings.
The Young Rheumatologists track provides three sessions with a special focus on researchers and clinicians who are early in their careers, Sofia Ramiro, MD, PhD, explained in an interview. Dr. Ramiro chairs the steering committee of the Emerging Eular Network (EMEUNET), a network of young clinicians and researchers in the field of rheumatology in Europe.
Another session will zero in on osteoarthritis, vasculitis, spondyloarthritis, and rheumatoid arthritis, with a shorter lecture format and more time left for a question-and-answer session and discussion. With a group of younger rheumatologists in attendance, “the sessions are somewhat more informal,” promoting a comfortable and interactive environment for discussion and learning, Dr. Ramiro said.
The third session in the Young Rheumatologists track will consist of case discussions focused on how to counsel and take care of women who have rheumatoid arthritis and would like to become pregnant. Two patient cases will be presented and discussed by leaders in the field. “Again, the idea is to make these presentations as real-world as possible,” Dr. Ramiro said.
The EMEUNET booth will be in the EULAR Village, and, for the first time, the booth will be incorporated in the EULAR booth, as a “pillar” under the bigger EULAR umbrella. Dr. Ramiro said to be sure to stay tuned for a surprise associated with EULAR’s 70th anniversary. On the evening of Thursday, June 15, EMEUNET will host a networking event.
On the morning of Friday, June 16, mentor-mentee meetings organized by EMEUNET link five to six young attendees with mentors, according to area of interest. Sign up is available online, allowing small group discussion with leaders in academic rheumatology. This year, meetings will be led by Iain McInnes, PhD (Glasgow, Scotland), Josef Smolen, MD (Vienna), and William Dixon, MBBS, PhD (Manchester, England). Mentorship topics can include the incorporation of research into a clinical career, general career advice, and insight into international collaboration, Dr. Ramiro said.
“These are usually very well-attended meetings and very popular,” she said. “People who have participated in them always give us very good feedback and are very enthusiastic about how easily accessible these very famous key opinion leaders are and what good advice they give to them.”
Finally, the Ambassador program helps first-time attendees get the most out of EULAR. “I think that we all know that the first time we attend such a huge conference the experience can be daunting,” Dr. Ramiro said. Now in its third year, the ambassador program pairs an EMEUNET member with up to six first-timers. The ambassador helps the newcomers decide which sessions to attend and remains available through mobile phone, social media, and the meeting app throughout the meeting.
All of EMEUNET’s activities during EULAR support the organization’s aim of “widening collaboration and fostering collaboration among young researchers and clinicians,” Dr. Ramiro said. “The ultimate aim is to improve and promote education in the area of our diseases and to foster research collaborations,” she said of the 1,500-member strong organization.
Young rheumatologists and researchers will find plenty of relevant content at this year’s EULAR Congress in Madrid, June 14-17, thanks to a dedicated presentation track. Other tailored opportunities include networking events, mentorship for first-time attendees to help them make the most of their EULAR experience, and a unique opportunity for small group discussion and networking with key opinion leaders in rheumatology in the so-called mentor-mentee meetings.
The Young Rheumatologists track provides three sessions with a special focus on researchers and clinicians who are early in their careers, Sofia Ramiro, MD, PhD, explained in an interview. Dr. Ramiro chairs the steering committee of the Emerging Eular Network (EMEUNET), a network of young clinicians and researchers in the field of rheumatology in Europe.
Another session will zero in on osteoarthritis, vasculitis, spondyloarthritis, and rheumatoid arthritis, with a shorter lecture format and more time left for a question-and-answer session and discussion. With a group of younger rheumatologists in attendance, “the sessions are somewhat more informal,” promoting a comfortable and interactive environment for discussion and learning, Dr. Ramiro said.
The third session in the Young Rheumatologists track will consist of case discussions focused on how to counsel and take care of women who have rheumatoid arthritis and would like to become pregnant. Two patient cases will be presented and discussed by leaders in the field. “Again, the idea is to make these presentations as real-world as possible,” Dr. Ramiro said.
The EMEUNET booth will be in the EULAR Village, and, for the first time, the booth will be incorporated in the EULAR booth, as a “pillar” under the bigger EULAR umbrella. Dr. Ramiro said to be sure to stay tuned for a surprise associated with EULAR’s 70th anniversary. On the evening of Thursday, June 15, EMEUNET will host a networking event.
On the morning of Friday, June 16, mentor-mentee meetings organized by EMEUNET link five to six young attendees with mentors, according to area of interest. Sign up is available online, allowing small group discussion with leaders in academic rheumatology. This year, meetings will be led by Iain McInnes, PhD (Glasgow, Scotland), Josef Smolen, MD (Vienna), and William Dixon, MBBS, PhD (Manchester, England). Mentorship topics can include the incorporation of research into a clinical career, general career advice, and insight into international collaboration, Dr. Ramiro said.
“These are usually very well-attended meetings and very popular,” she said. “People who have participated in them always give us very good feedback and are very enthusiastic about how easily accessible these very famous key opinion leaders are and what good advice they give to them.”
Finally, the Ambassador program helps first-time attendees get the most out of EULAR. “I think that we all know that the first time we attend such a huge conference the experience can be daunting,” Dr. Ramiro said. Now in its third year, the ambassador program pairs an EMEUNET member with up to six first-timers. The ambassador helps the newcomers decide which sessions to attend and remains available through mobile phone, social media, and the meeting app throughout the meeting.
All of EMEUNET’s activities during EULAR support the organization’s aim of “widening collaboration and fostering collaboration among young researchers and clinicians,” Dr. Ramiro said. “The ultimate aim is to improve and promote education in the area of our diseases and to foster research collaborations,” she said of the 1,500-member strong organization.
ABP 501 equivalent in efficacy to adalimumab for moderate to severe RA
The biosimilar ABP 501 is equally as effective and safe as adalimumab for the treatment of moderate to severe rheumatoid arthritis, according to results of a phase III clinical trial.
In a randomized, double-blind equivalence study across 100 medical centers in 12 countries, 526 patients with moderate to severe RA and inadequate response to methotrexate received either ABP 501 or adalimumab. Of the 526, 494 completed the study. Just over 80% of patients were women, and 95.1% were white, with a mean age of 55.9 years. Patients received either 40-mg ABP 501 or adalimumab subcutaneously on day 1 and every 2 weeks until week 22, with primary endpoint assessments conducted after 24 weeks, according to Dr. Stanley Cohen and his associates (Ann Rheum Dis. 2017 Jun 5. doi: 10.1136/annrheumdis-2016-210459).
Treatment-emergent adverse events occurred in 132 of the 264 patients in the ABP 501 group and in 143 of the 262 patients in the adalimumab group. Common treatment-emergent adverse events in both groups included nasopharyngitis, headache, arthralgia, cough, and upper respiratory infection. Serious adverse events occurred in 10 patients who received ABP 501 and in 13 patients who received adalimumab. Sepsis was the only serious adverse event that occurred in more than one patient.
Over the course of the study, 38.3% of patients who received ABP 501 and 38.2% of patients who received adalimumab tested positive for binding antidrug antibodies.
The study data “contribute to the totality-of-evidence–based requirements to demonstrate that ABP 501 is similar to adalimumab. The FDA has, thus, approved ABP 501 for use as a biosimilar to adalimumab, making it a valuable new therapeutic option for the treatment of moderate to severe RA,” Dr. Cohen and his associates concluded.
The study was funded by Amgen. Dr. Cohen and five of his associates reported conflicts of interest. Two investigators are employees of Amgen.
The biosimilar ABP 501 is equally as effective and safe as adalimumab for the treatment of moderate to severe rheumatoid arthritis, according to results of a phase III clinical trial.
In a randomized, double-blind equivalence study across 100 medical centers in 12 countries, 526 patients with moderate to severe RA and inadequate response to methotrexate received either ABP 501 or adalimumab. Of the 526, 494 completed the study. Just over 80% of patients were women, and 95.1% were white, with a mean age of 55.9 years. Patients received either 40-mg ABP 501 or adalimumab subcutaneously on day 1 and every 2 weeks until week 22, with primary endpoint assessments conducted after 24 weeks, according to Dr. Stanley Cohen and his associates (Ann Rheum Dis. 2017 Jun 5. doi: 10.1136/annrheumdis-2016-210459).
Treatment-emergent adverse events occurred in 132 of the 264 patients in the ABP 501 group and in 143 of the 262 patients in the adalimumab group. Common treatment-emergent adverse events in both groups included nasopharyngitis, headache, arthralgia, cough, and upper respiratory infection. Serious adverse events occurred in 10 patients who received ABP 501 and in 13 patients who received adalimumab. Sepsis was the only serious adverse event that occurred in more than one patient.
Over the course of the study, 38.3% of patients who received ABP 501 and 38.2% of patients who received adalimumab tested positive for binding antidrug antibodies.
The study data “contribute to the totality-of-evidence–based requirements to demonstrate that ABP 501 is similar to adalimumab. The FDA has, thus, approved ABP 501 for use as a biosimilar to adalimumab, making it a valuable new therapeutic option for the treatment of moderate to severe RA,” Dr. Cohen and his associates concluded.
The study was funded by Amgen. Dr. Cohen and five of his associates reported conflicts of interest. Two investigators are employees of Amgen.
The biosimilar ABP 501 is equally as effective and safe as adalimumab for the treatment of moderate to severe rheumatoid arthritis, according to results of a phase III clinical trial.
In a randomized, double-blind equivalence study across 100 medical centers in 12 countries, 526 patients with moderate to severe RA and inadequate response to methotrexate received either ABP 501 or adalimumab. Of the 526, 494 completed the study. Just over 80% of patients were women, and 95.1% were white, with a mean age of 55.9 years. Patients received either 40-mg ABP 501 or adalimumab subcutaneously on day 1 and every 2 weeks until week 22, with primary endpoint assessments conducted after 24 weeks, according to Dr. Stanley Cohen and his associates (Ann Rheum Dis. 2017 Jun 5. doi: 10.1136/annrheumdis-2016-210459).
Treatment-emergent adverse events occurred in 132 of the 264 patients in the ABP 501 group and in 143 of the 262 patients in the adalimumab group. Common treatment-emergent adverse events in both groups included nasopharyngitis, headache, arthralgia, cough, and upper respiratory infection. Serious adverse events occurred in 10 patients who received ABP 501 and in 13 patients who received adalimumab. Sepsis was the only serious adverse event that occurred in more than one patient.
Over the course of the study, 38.3% of patients who received ABP 501 and 38.2% of patients who received adalimumab tested positive for binding antidrug antibodies.
The study data “contribute to the totality-of-evidence–based requirements to demonstrate that ABP 501 is similar to adalimumab. The FDA has, thus, approved ABP 501 for use as a biosimilar to adalimumab, making it a valuable new therapeutic option for the treatment of moderate to severe RA,” Dr. Cohen and his associates concluded.
The study was funded by Amgen. Dr. Cohen and five of his associates reported conflicts of interest. Two investigators are employees of Amgen.
FROM ANNALS OF THE RHEUMATIC DISEASES
Key clinical point:
Major finding: Adequate ACR 20 response occurred in 74.6% of patients receiving ABP 501 and in 72.4% of patients receiving adalimumab.
Data source: A randomized, double-blind equivalence study across 100 medical centers in 12 countries of 526 patients with moderate to severe RA.
Disclosures: The study was funded by Amgen. Dr. Cohen and five of his associated reported conflicts of interest. Two investigators are employees of Amgen.
Biologics after methotrexate fails: Huge cost, minimal benefit
Prescribing rheumatoid arthritis patients a biologic agent rather than triple therapy, when they fail to respond adequately to methotrexate, costs more than half a million dollars per quality-adjusted life year gained over a lifetime but provides only a minimal health benefit beyond triple therapy, according to a report published online May 30 in Annals of Internal Medicine.
The evidence is clear that triple therapy using sulfasalazine, hydroxychloroquine, and methotrexate is at least as effective as methotrexate plus an anti–tumor necrosis factor biologic (etanercept, adalimumab, infliximab, golimumab, or certolizumab pegol). Nevertheless, few RA patients are transitioned to triple therapy before escalating to biologics. This occurred in only 2.5% of patients in one Veterans Affairs study, said Nick Bansback, PhD, of the University of British Columbia and St. Paul’s Hospital, Vancouver, and his associates.
Dr. Bansback and his colleagues performed a cost-effectiveness study of proceeding directly to etanercept when RA fails to respond to methotrexate, using data from the Rheumatoid Arthritis Comparison of Active Therapies (RACAT) trial. The RACAT study, a large international, randomized, double-blind trial, confirmed the clinical noninferiority of triple therapy versus etanercept plus methotrexate. In their analysis, Dr. Bansback and his associates calculated the costs and QALYs for both treatment strategies for 324 RACAT participants.
Switching directly to etanercept-methotrexate instead of triple therapy provided only a marginal advantage in QALYs, a difference of only 0.004 QALY over 24 weeks of treatment (0.358 with etanercept-methotrexate vs. 0.353 with triple therapy) and of only 0.016 QALY over 48 weeks of treatment (0.743 with etanercept-methotrexate vs. 0.726 with triple therapy). The associated costs were $11,295 for 24 weeks of etanercept-methotrexate, vs. $343 for 24 weeks of triple therapy, and $19,634 for 48 weeks of etanercept-methotrexate, vs. $3,680 for 48 weeks of triple therapy.
“The resultant ICER [incremental cost-effectiveness ratio] for first-line etanercept-methotrexate, vs. triple therapy, was $2.7 million per QALY gained over 24 weeks,” the investigators said (Ann Intern Med. 2017 May 29. doi: 10.7326/M16-0713).
When they extrapolated the data to determine the cost-effectiveness of the two treatment strategies over the course of the average patient’s lifetime, the model predicted an ICER of $521,520 per QALY gained for etanercept-methotrexate instead of triple therapy. These findings remained robust in numerous sensitivity and scenario analyses. For example, when the model assumed that radiographic and quality of life benefits of triple therapy were far lower than observed in the RACAT trial and far lower than what has been reported in the literature and that the tolerability of triple therapy was far worse than observed in the RACAT trial and reported in the literature, switching to etanercept-methotrexate instead of triple therapy still predicted an ICER of $350,000 per QALY per patient.
All of these ICERs far exceed the standard cost-effectiveness acceptability threshold ICER of $100,000 per QALY, Dr. Bansback and his associates noted.
This study demonstrates the substantial cost savings of prescribing triple therapy before a biologic. It shows that “for every patient who tries triple therapy before a biologic, payers will save an average of $78,000 over the patient’s lifetime, and most of the savings will accrue within the first 10 years,” the investigators wrote.
“Patients who receive triple therapy before a biologic will miss out on a benefit of approximately 0.15 QALY over their lifetime or a benefit of approximately 0.05 HAQ [Health Assessment Questionnaire] point at any point in time. To put these numbers in perspective, total hip arthroplasty in a patient with osteoarthritis who is approximately the same age as an average patient with RA provides an additional 6.9 QALYs. In terms of HAQ score, only differences greater than 0.2 points are considered minimally important to patients,” Dr. Bansback and his associates wrote.
Changing health care policy to require, rather than to just recommend, that triple therapy be prescribed before biologics would save millions of dollars in health care expenditures, they added.
This study was supported by the U.S. Department of Veterans Affairs Office of Research and Development, the Canadian Institutes for Health Research, the National Institutes of Health, and the American Recovery and Reinvestment Act. Dr. Bansback reported having no relevant financial disclosures. His associates reported ties to numerous industry sources.
The findings of Bansback et al., consistent with those of several other researchers, indicate that patients who have RA and no contraindications to triple-conventional, disease-modifying antirheumatic drug therapy should use therapy instead of biologics as the next regimen if methotrexate alone fails to control symptoms and radiographic progression.
Elena Losina, PhD, and Jeffrey N. Katz, MD, are at Brigham and Women’s Hospital in Boston. They disclosed having no conflicts of interest. Dr. Losina and Dr. Katz made these remarks in an editorial accompanying Dr. Bansback’s report (Ann Intern Med. 2017 May 29. doi: 10.7326/M17-1176).
The findings of Bansback et al., consistent with those of several other researchers, indicate that patients who have RA and no contraindications to triple-conventional, disease-modifying antirheumatic drug therapy should use therapy instead of biologics as the next regimen if methotrexate alone fails to control symptoms and radiographic progression.
Elena Losina, PhD, and Jeffrey N. Katz, MD, are at Brigham and Women’s Hospital in Boston. They disclosed having no conflicts of interest. Dr. Losina and Dr. Katz made these remarks in an editorial accompanying Dr. Bansback’s report (Ann Intern Med. 2017 May 29. doi: 10.7326/M17-1176).
The findings of Bansback et al., consistent with those of several other researchers, indicate that patients who have RA and no contraindications to triple-conventional, disease-modifying antirheumatic drug therapy should use therapy instead of biologics as the next regimen if methotrexate alone fails to control symptoms and radiographic progression.
Elena Losina, PhD, and Jeffrey N. Katz, MD, are at Brigham and Women’s Hospital in Boston. They disclosed having no conflicts of interest. Dr. Losina and Dr. Katz made these remarks in an editorial accompanying Dr. Bansback’s report (Ann Intern Med. 2017 May 29. doi: 10.7326/M17-1176).
Prescribing rheumatoid arthritis patients a biologic agent rather than triple therapy, when they fail to respond adequately to methotrexate, costs more than half a million dollars per quality-adjusted life year gained over a lifetime but provides only a minimal health benefit beyond triple therapy, according to a report published online May 30 in Annals of Internal Medicine.
The evidence is clear that triple therapy using sulfasalazine, hydroxychloroquine, and methotrexate is at least as effective as methotrexate plus an anti–tumor necrosis factor biologic (etanercept, adalimumab, infliximab, golimumab, or certolizumab pegol). Nevertheless, few RA patients are transitioned to triple therapy before escalating to biologics. This occurred in only 2.5% of patients in one Veterans Affairs study, said Nick Bansback, PhD, of the University of British Columbia and St. Paul’s Hospital, Vancouver, and his associates.
Dr. Bansback and his colleagues performed a cost-effectiveness study of proceeding directly to etanercept when RA fails to respond to methotrexate, using data from the Rheumatoid Arthritis Comparison of Active Therapies (RACAT) trial. The RACAT study, a large international, randomized, double-blind trial, confirmed the clinical noninferiority of triple therapy versus etanercept plus methotrexate. In their analysis, Dr. Bansback and his associates calculated the costs and QALYs for both treatment strategies for 324 RACAT participants.
Switching directly to etanercept-methotrexate instead of triple therapy provided only a marginal advantage in QALYs, a difference of only 0.004 QALY over 24 weeks of treatment (0.358 with etanercept-methotrexate vs. 0.353 with triple therapy) and of only 0.016 QALY over 48 weeks of treatment (0.743 with etanercept-methotrexate vs. 0.726 with triple therapy). The associated costs were $11,295 for 24 weeks of etanercept-methotrexate, vs. $343 for 24 weeks of triple therapy, and $19,634 for 48 weeks of etanercept-methotrexate, vs. $3,680 for 48 weeks of triple therapy.
“The resultant ICER [incremental cost-effectiveness ratio] for first-line etanercept-methotrexate, vs. triple therapy, was $2.7 million per QALY gained over 24 weeks,” the investigators said (Ann Intern Med. 2017 May 29. doi: 10.7326/M16-0713).
When they extrapolated the data to determine the cost-effectiveness of the two treatment strategies over the course of the average patient’s lifetime, the model predicted an ICER of $521,520 per QALY gained for etanercept-methotrexate instead of triple therapy. These findings remained robust in numerous sensitivity and scenario analyses. For example, when the model assumed that radiographic and quality of life benefits of triple therapy were far lower than observed in the RACAT trial and far lower than what has been reported in the literature and that the tolerability of triple therapy was far worse than observed in the RACAT trial and reported in the literature, switching to etanercept-methotrexate instead of triple therapy still predicted an ICER of $350,000 per QALY per patient.
All of these ICERs far exceed the standard cost-effectiveness acceptability threshold ICER of $100,000 per QALY, Dr. Bansback and his associates noted.
This study demonstrates the substantial cost savings of prescribing triple therapy before a biologic. It shows that “for every patient who tries triple therapy before a biologic, payers will save an average of $78,000 over the patient’s lifetime, and most of the savings will accrue within the first 10 years,” the investigators wrote.
“Patients who receive triple therapy before a biologic will miss out on a benefit of approximately 0.15 QALY over their lifetime or a benefit of approximately 0.05 HAQ [Health Assessment Questionnaire] point at any point in time. To put these numbers in perspective, total hip arthroplasty in a patient with osteoarthritis who is approximately the same age as an average patient with RA provides an additional 6.9 QALYs. In terms of HAQ score, only differences greater than 0.2 points are considered minimally important to patients,” Dr. Bansback and his associates wrote.
Changing health care policy to require, rather than to just recommend, that triple therapy be prescribed before biologics would save millions of dollars in health care expenditures, they added.
This study was supported by the U.S. Department of Veterans Affairs Office of Research and Development, the Canadian Institutes for Health Research, the National Institutes of Health, and the American Recovery and Reinvestment Act. Dr. Bansback reported having no relevant financial disclosures. His associates reported ties to numerous industry sources.
Prescribing rheumatoid arthritis patients a biologic agent rather than triple therapy, when they fail to respond adequately to methotrexate, costs more than half a million dollars per quality-adjusted life year gained over a lifetime but provides only a minimal health benefit beyond triple therapy, according to a report published online May 30 in Annals of Internal Medicine.
The evidence is clear that triple therapy using sulfasalazine, hydroxychloroquine, and methotrexate is at least as effective as methotrexate plus an anti–tumor necrosis factor biologic (etanercept, adalimumab, infliximab, golimumab, or certolizumab pegol). Nevertheless, few RA patients are transitioned to triple therapy before escalating to biologics. This occurred in only 2.5% of patients in one Veterans Affairs study, said Nick Bansback, PhD, of the University of British Columbia and St. Paul’s Hospital, Vancouver, and his associates.
Dr. Bansback and his colleagues performed a cost-effectiveness study of proceeding directly to etanercept when RA fails to respond to methotrexate, using data from the Rheumatoid Arthritis Comparison of Active Therapies (RACAT) trial. The RACAT study, a large international, randomized, double-blind trial, confirmed the clinical noninferiority of triple therapy versus etanercept plus methotrexate. In their analysis, Dr. Bansback and his associates calculated the costs and QALYs for both treatment strategies for 324 RACAT participants.
Switching directly to etanercept-methotrexate instead of triple therapy provided only a marginal advantage in QALYs, a difference of only 0.004 QALY over 24 weeks of treatment (0.358 with etanercept-methotrexate vs. 0.353 with triple therapy) and of only 0.016 QALY over 48 weeks of treatment (0.743 with etanercept-methotrexate vs. 0.726 with triple therapy). The associated costs were $11,295 for 24 weeks of etanercept-methotrexate, vs. $343 for 24 weeks of triple therapy, and $19,634 for 48 weeks of etanercept-methotrexate, vs. $3,680 for 48 weeks of triple therapy.
“The resultant ICER [incremental cost-effectiveness ratio] for first-line etanercept-methotrexate, vs. triple therapy, was $2.7 million per QALY gained over 24 weeks,” the investigators said (Ann Intern Med. 2017 May 29. doi: 10.7326/M16-0713).
When they extrapolated the data to determine the cost-effectiveness of the two treatment strategies over the course of the average patient’s lifetime, the model predicted an ICER of $521,520 per QALY gained for etanercept-methotrexate instead of triple therapy. These findings remained robust in numerous sensitivity and scenario analyses. For example, when the model assumed that radiographic and quality of life benefits of triple therapy were far lower than observed in the RACAT trial and far lower than what has been reported in the literature and that the tolerability of triple therapy was far worse than observed in the RACAT trial and reported in the literature, switching to etanercept-methotrexate instead of triple therapy still predicted an ICER of $350,000 per QALY per patient.
All of these ICERs far exceed the standard cost-effectiveness acceptability threshold ICER of $100,000 per QALY, Dr. Bansback and his associates noted.
This study demonstrates the substantial cost savings of prescribing triple therapy before a biologic. It shows that “for every patient who tries triple therapy before a biologic, payers will save an average of $78,000 over the patient’s lifetime, and most of the savings will accrue within the first 10 years,” the investigators wrote.
“Patients who receive triple therapy before a biologic will miss out on a benefit of approximately 0.15 QALY over their lifetime or a benefit of approximately 0.05 HAQ [Health Assessment Questionnaire] point at any point in time. To put these numbers in perspective, total hip arthroplasty in a patient with osteoarthritis who is approximately the same age as an average patient with RA provides an additional 6.9 QALYs. In terms of HAQ score, only differences greater than 0.2 points are considered minimally important to patients,” Dr. Bansback and his associates wrote.
Changing health care policy to require, rather than to just recommend, that triple therapy be prescribed before biologics would save millions of dollars in health care expenditures, they added.
This study was supported by the U.S. Department of Veterans Affairs Office of Research and Development, the Canadian Institutes for Health Research, the National Institutes of Health, and the American Recovery and Reinvestment Act. Dr. Bansback reported having no relevant financial disclosures. His associates reported ties to numerous industry sources.
FROM ANNALS OF INTERNAL MEDICINE
Key clinical point:
Major finding: For every RA patient who tries triple therapy before a biologic, payers will save an average of $78,000 over the patient’s lifetime without sacrificing their health or quality of life.
Data source: A cost-effectiveness analysis using data from 324 participants in an international, randomized, double-blind trial.
Disclosures: This study was supported by the U.S. Department of Veterans Affairs Office of Research and Development, the Canadian Institutes for Health Research, the National Institutes of Health, and the American Recovery and Reinvestment Act. Dr. Bansback reported having no relevant financial disclosures. His associates reported ties to numerous industry sources.
FDA approves sarilumab for DMARD-intolerant RA patients
The Food and Drug Administration has approved sarilumab (Kevzara), a human monoclonal antibody against the interleukin-6 receptor, for the treatment of adult patients with rheumatoid arthritis (RA), the manufacturer Regeneron Pharmaceuticals announced May 22.
Interleukin-6 is an important factor in RA, as excess amounts of IL-6 build up in the body and contribute to RA-associated inflammation. Sarilumab has been shown to bind to and reduce IL-6R signaling, and is intended for people who have shown inadequate response to or are intolerant to conventional synthetic disease-modifying antirheumatic drugs (DMARDs).
“Not all currently available treatments work in all patients, and some patients may spend years cycling through different treatments without achieving their treatment goals. Sarilumab works differently from the most commonly used biologics, such as those in the anti-TNF [tumor necrosis factor] class, and is a welcome new option for patients and their physicians,” Alan Kivitz, MD, an investigator in sarilumab clinical trials and a rheumatologist in group practice in Duncansville, Pa., said in Regeneron’s announcement.
The recommended dosage of sarilumab is 200 mg once every 2 weeks given as a subcutaneous injection, which can be self-administered. The dosage can be reduced from 200 mg to 150 mg once every 2 weeks, as needed, to help manage certain laboratory abnormalities (neutropenia, thrombocytopenia, and liver enzyme elevations). Significant adverse events associated with sarilumab include weakening of the immune system, changes in certain laboratory tests, perforation in the stomach or intestines, increased risk of cancer, and serious allergic reaction.
The Food and Drug Administration has approved sarilumab (Kevzara), a human monoclonal antibody against the interleukin-6 receptor, for the treatment of adult patients with rheumatoid arthritis (RA), the manufacturer Regeneron Pharmaceuticals announced May 22.
Interleukin-6 is an important factor in RA, as excess amounts of IL-6 build up in the body and contribute to RA-associated inflammation. Sarilumab has been shown to bind to and reduce IL-6R signaling, and is intended for people who have shown inadequate response to or are intolerant to conventional synthetic disease-modifying antirheumatic drugs (DMARDs).
“Not all currently available treatments work in all patients, and some patients may spend years cycling through different treatments without achieving their treatment goals. Sarilumab works differently from the most commonly used biologics, such as those in the anti-TNF [tumor necrosis factor] class, and is a welcome new option for patients and their physicians,” Alan Kivitz, MD, an investigator in sarilumab clinical trials and a rheumatologist in group practice in Duncansville, Pa., said in Regeneron’s announcement.
The recommended dosage of sarilumab is 200 mg once every 2 weeks given as a subcutaneous injection, which can be self-administered. The dosage can be reduced from 200 mg to 150 mg once every 2 weeks, as needed, to help manage certain laboratory abnormalities (neutropenia, thrombocytopenia, and liver enzyme elevations). Significant adverse events associated with sarilumab include weakening of the immune system, changes in certain laboratory tests, perforation in the stomach or intestines, increased risk of cancer, and serious allergic reaction.
The Food and Drug Administration has approved sarilumab (Kevzara), a human monoclonal antibody against the interleukin-6 receptor, for the treatment of adult patients with rheumatoid arthritis (RA), the manufacturer Regeneron Pharmaceuticals announced May 22.
Interleukin-6 is an important factor in RA, as excess amounts of IL-6 build up in the body and contribute to RA-associated inflammation. Sarilumab has been shown to bind to and reduce IL-6R signaling, and is intended for people who have shown inadequate response to or are intolerant to conventional synthetic disease-modifying antirheumatic drugs (DMARDs).
“Not all currently available treatments work in all patients, and some patients may spend years cycling through different treatments without achieving their treatment goals. Sarilumab works differently from the most commonly used biologics, such as those in the anti-TNF [tumor necrosis factor] class, and is a welcome new option for patients and their physicians,” Alan Kivitz, MD, an investigator in sarilumab clinical trials and a rheumatologist in group practice in Duncansville, Pa., said in Regeneron’s announcement.
The recommended dosage of sarilumab is 200 mg once every 2 weeks given as a subcutaneous injection, which can be self-administered. The dosage can be reduced from 200 mg to 150 mg once every 2 weeks, as needed, to help manage certain laboratory abnormalities (neutropenia, thrombocytopenia, and liver enzyme elevations). Significant adverse events associated with sarilumab include weakening of the immune system, changes in certain laboratory tests, perforation in the stomach or intestines, increased risk of cancer, and serious allergic reaction.
Intervention improves use of treat to target in RA
A learning collaborative approach can significantly improve adherence to a treat-to-target approach in patients with rheumatoid arthritis, new research suggests.
While numerous clinical trials have shown that a strategy of treating to target achieves better outcomes, compared with usual care, there is evidence that this approach is not always practiced, wrote Daniel H. Solomon, MD, of the division of rheumatology at Brigham and Women’s Hospital, Boston, and his coauthors.
The intervention first involved the faculty developing a set of principles and concepts to describe the goals for implementing treat to target. These were then disseminated to the sites through a single face-to-face learning session and a series of webinars, which were also recorded and made available online. The first session also worked on team building within sites and on cross-site collaborative relationships.
“In this study, we found large benefits, despite using a relatively low-intensity approach to the learning collaborative, with only one face-to-face meeting,” wrote the authors, who noted that altogether the program involved around 20 hours per provider over 9 months.
The investigators used a composite treat-to-target implementation score as the primary outcome, which was based on the presence or absence of four measures deemed central to the principles and concepts of a treat-to-target strategy. The measures were:
- Specifying a disease activity target.
- Recording RA disease activity, using one of four recommended measures (Disease Activity Score-28, Simplified Disease Activity Index, Clinical Disease Activity Index, or Routine Assessment of Patient Index Data 3), with results described numerically or by category (remission, low, moderate, or high).
- When a decision was being made (change in target or change in treatment), documenting shared decision making.
- Basing treatment decisions on target and disease activity measure or describing reasons why treat to target was not adhered to.
The intervention increased the treat-to-target implementation score by 46 percentage points, from 11% to 57%. In comparison, the control arm had an increase of 14 percentage points, from 11% to 25% (P = .004). It achieved a substantial and significant increase in the proportion of participants for whom a treatment target was documented, from 0.6% at baseline to 45.6% at the 9-month follow-up, compared with a 12.5-point increase in the control group. The recording of disease activity increased from 20% to 89.1% in the intervention arm, compared with an increase from 30.2% to 52.3% in the control arm. Similarly, shared decision making increased from 51.3% to 85.9% in the intervention group, compared with a rise from 24.5% to 43% in the control arm.
The study also examined a range of secondary outcomes representing the impact of the intervention on patients. They found that a positive change in treat-to-target adherence score was seen in 83.8% of patients in the intervention arm, compared with 36.8% of patients in the control arm (P = .0001), when almost no patient visits at baseline were adherent to all components of treat to target.
At the 9-month follow-up, 25.9% of visits in the intervention arm were adherent to all four components of the treat-to-target approach, compared with 5.6% in the control arm.
The authors suggested that their learning collaborative approach could be applied across a range of chronic diseases.
“In fact, our model is consistent with the goals and strategy of the Million Hearts campaign to reduce cardiovascular disease burden across the U.S. by targeting five areas of goal-based therapy.”
There were no significant differences between the intervention and control arms in the number of orders for drug-monitoring laboratory tests or radiology orders. However, patients in the intervention arm had fewer adverse events than did those in the control arm (0.26 vs. 0.43 per patient; P = .043).
The investigators noted that the study was relatively small – involving just 11 sites – and the primary outcome was a process measure that did not reflect clinical outcomes and has not been validated.
The study was supported by the National Institutes of Health. One author declared salary support through research grants to his hospital from pharmaceutical companies, while another declared research grants from AbbVie for treat-to-target research activities.
A learning collaborative approach can significantly improve adherence to a treat-to-target approach in patients with rheumatoid arthritis, new research suggests.
While numerous clinical trials have shown that a strategy of treating to target achieves better outcomes, compared with usual care, there is evidence that this approach is not always practiced, wrote Daniel H. Solomon, MD, of the division of rheumatology at Brigham and Women’s Hospital, Boston, and his coauthors.
The intervention first involved the faculty developing a set of principles and concepts to describe the goals for implementing treat to target. These were then disseminated to the sites through a single face-to-face learning session and a series of webinars, which were also recorded and made available online. The first session also worked on team building within sites and on cross-site collaborative relationships.
“In this study, we found large benefits, despite using a relatively low-intensity approach to the learning collaborative, with only one face-to-face meeting,” wrote the authors, who noted that altogether the program involved around 20 hours per provider over 9 months.
The investigators used a composite treat-to-target implementation score as the primary outcome, which was based on the presence or absence of four measures deemed central to the principles and concepts of a treat-to-target strategy. The measures were:
- Specifying a disease activity target.
- Recording RA disease activity, using one of four recommended measures (Disease Activity Score-28, Simplified Disease Activity Index, Clinical Disease Activity Index, or Routine Assessment of Patient Index Data 3), with results described numerically or by category (remission, low, moderate, or high).
- When a decision was being made (change in target or change in treatment), documenting shared decision making.
- Basing treatment decisions on target and disease activity measure or describing reasons why treat to target was not adhered to.
The intervention increased the treat-to-target implementation score by 46 percentage points, from 11% to 57%. In comparison, the control arm had an increase of 14 percentage points, from 11% to 25% (P = .004). It achieved a substantial and significant increase in the proportion of participants for whom a treatment target was documented, from 0.6% at baseline to 45.6% at the 9-month follow-up, compared with a 12.5-point increase in the control group. The recording of disease activity increased from 20% to 89.1% in the intervention arm, compared with an increase from 30.2% to 52.3% in the control arm. Similarly, shared decision making increased from 51.3% to 85.9% in the intervention group, compared with a rise from 24.5% to 43% in the control arm.
The study also examined a range of secondary outcomes representing the impact of the intervention on patients. They found that a positive change in treat-to-target adherence score was seen in 83.8% of patients in the intervention arm, compared with 36.8% of patients in the control arm (P = .0001), when almost no patient visits at baseline were adherent to all components of treat to target.
At the 9-month follow-up, 25.9% of visits in the intervention arm were adherent to all four components of the treat-to-target approach, compared with 5.6% in the control arm.
The authors suggested that their learning collaborative approach could be applied across a range of chronic diseases.
“In fact, our model is consistent with the goals and strategy of the Million Hearts campaign to reduce cardiovascular disease burden across the U.S. by targeting five areas of goal-based therapy.”
There were no significant differences between the intervention and control arms in the number of orders for drug-monitoring laboratory tests or radiology orders. However, patients in the intervention arm had fewer adverse events than did those in the control arm (0.26 vs. 0.43 per patient; P = .043).
The investigators noted that the study was relatively small – involving just 11 sites – and the primary outcome was a process measure that did not reflect clinical outcomes and has not been validated.
The study was supported by the National Institutes of Health. One author declared salary support through research grants to his hospital from pharmaceutical companies, while another declared research grants from AbbVie for treat-to-target research activities.
A learning collaborative approach can significantly improve adherence to a treat-to-target approach in patients with rheumatoid arthritis, new research suggests.
While numerous clinical trials have shown that a strategy of treating to target achieves better outcomes, compared with usual care, there is evidence that this approach is not always practiced, wrote Daniel H. Solomon, MD, of the division of rheumatology at Brigham and Women’s Hospital, Boston, and his coauthors.
The intervention first involved the faculty developing a set of principles and concepts to describe the goals for implementing treat to target. These were then disseminated to the sites through a single face-to-face learning session and a series of webinars, which were also recorded and made available online. The first session also worked on team building within sites and on cross-site collaborative relationships.
“In this study, we found large benefits, despite using a relatively low-intensity approach to the learning collaborative, with only one face-to-face meeting,” wrote the authors, who noted that altogether the program involved around 20 hours per provider over 9 months.
The investigators used a composite treat-to-target implementation score as the primary outcome, which was based on the presence or absence of four measures deemed central to the principles and concepts of a treat-to-target strategy. The measures were:
- Specifying a disease activity target.
- Recording RA disease activity, using one of four recommended measures (Disease Activity Score-28, Simplified Disease Activity Index, Clinical Disease Activity Index, or Routine Assessment of Patient Index Data 3), with results described numerically or by category (remission, low, moderate, or high).
- When a decision was being made (change in target or change in treatment), documenting shared decision making.
- Basing treatment decisions on target and disease activity measure or describing reasons why treat to target was not adhered to.
The intervention increased the treat-to-target implementation score by 46 percentage points, from 11% to 57%. In comparison, the control arm had an increase of 14 percentage points, from 11% to 25% (P = .004). It achieved a substantial and significant increase in the proportion of participants for whom a treatment target was documented, from 0.6% at baseline to 45.6% at the 9-month follow-up, compared with a 12.5-point increase in the control group. The recording of disease activity increased from 20% to 89.1% in the intervention arm, compared with an increase from 30.2% to 52.3% in the control arm. Similarly, shared decision making increased from 51.3% to 85.9% in the intervention group, compared with a rise from 24.5% to 43% in the control arm.
The study also examined a range of secondary outcomes representing the impact of the intervention on patients. They found that a positive change in treat-to-target adherence score was seen in 83.8% of patients in the intervention arm, compared with 36.8% of patients in the control arm (P = .0001), when almost no patient visits at baseline were adherent to all components of treat to target.
At the 9-month follow-up, 25.9% of visits in the intervention arm were adherent to all four components of the treat-to-target approach, compared with 5.6% in the control arm.
The authors suggested that their learning collaborative approach could be applied across a range of chronic diseases.
“In fact, our model is consistent with the goals and strategy of the Million Hearts campaign to reduce cardiovascular disease burden across the U.S. by targeting five areas of goal-based therapy.”
There were no significant differences between the intervention and control arms in the number of orders for drug-monitoring laboratory tests or radiology orders. However, patients in the intervention arm had fewer adverse events than did those in the control arm (0.26 vs. 0.43 per patient; P = .043).
The investigators noted that the study was relatively small – involving just 11 sites – and the primary outcome was a process measure that did not reflect clinical outcomes and has not been validated.
The study was supported by the National Institutes of Health. One author declared salary support through research grants to his hospital from pharmaceutical companies, while another declared research grants from AbbVie for treat-to-target research activities.
FROM ARTHRITIS & RHEUMATOLOGY
Key clinical point:
Major finding: A site-based intervention increased a treat-to-target implementation score by 46 percentage points – from 11% to 57% – compared with a 14–percentage point increase in the control arm.
Data source: The cluster-randomized, wait list–controlled, quality improvement TRACTION trial, involving 11 sites and 641 patients.
Disclosures: The study was supported by the National Institutes of Health. One author declared salary support through research grants to his hospital from pharmaceutical companies, while another declared research grants from AbbVie for treat-to-target research activities.
Screen for comorbidities in pyoderma gangrenosum
PORTLAND, ORE. – Comorbidities were common in patients with pyoderma gangrenosum (PG), in a single-center retrospective cohort study of 130 patients.
These comorbid diagnoses were not only clinically significant in themselves, but also were associated with changes in treatment efficacy, highlighting the need for holistic surveillance of patients with PG, Alexander Fischer, MPH, said during an oral presentation of his poster at the annual meeting of the Society for Investigative Dermatology. “We should really be screening patients with PG for multiple comorbid conditions,” he emphasized. 
The study included patients seen for PG at Johns Hopkins Medicine, Baltimore, between 2006 and 2015. The most common comorbidity was inflammatory bowel disease (35%), followed by hidradenitis suppurativa (14%), rheumatoid arthritis (12%), monoclonal gammopathy (12%), leukemia (2%), and lymphoma (2%). “Interestingly, a substantial proportion of patients had multiple systemic diseases,” Mr. Fischer said. “For example, among our PG patients with rheumatoid arthritis, over a third also had comorbid inflammatory bowel disease. We saw this pattern repeat itself in patients with comorbid hidradenitis suppurativa, and also in patients with comorbid monoclonal gammopathy.”
The researchers used rigorous inclusion and exclusion criteria to verify the diagnosis of PG, said Mr. Fischer, a medical student at Johns Hopkins University, Baltimore, who conducted the analysis under the mentorship of Gerald S. Lazarus, MD, professor of dermatology and medicine at Johns Hopkins Bayview Medical Center. A total of 69% of patients were female, 58% were white, and 35% were black. The average age of PG onset was 47 years. Notably, patients with comorbid hidradenitis suppurativa (HS) had an earlier age of PG onset and were more likely to be black than were patients without comorbid HS, and 53% of young black females with PG onset also had HS.
The investigators explored whether the effect of systemic PG therapies varied in the presence of comorbidities. In a crude analysis of 32 patients who received infliximab (Remicade) for PG, those with comorbid HS were significantly more likely to achieve complete healing of PG wounds (83%) than were those without comorbid HS (31%; P = .03), Mr. Fischer reported. “Our sample size was small for this analysis, but we thought this was an interesting finding that perhaps warrants further investigation,” he said. “We need to do larger longitudinal studies that account for wound characteristics and that include more therapies to get a better grasp of this question.”
Only 57% of patients in this study had their diagnosis confirmed by biopsy, Mr. Fischer noted. However, this study generally resembles others in terms of comorbidity prevalence. For example, a single-center study of 103 patients with PG at Brigham and Women’s Hospital, Boston, found that 34% of patients had comorbid IBD compared with 35% in the Hopkins cohort (Br J Dermatol. 2011 Dec;165[6]:1244-50). In a study of 121 patients with PG at three wound care centers in Germany, 10% of patients had IBD, but 14% had rheumatologic conditions and 7% had blood cancers (J Dtsch Dermatol Ges. 2016 Oct;14[10]:1023-30).
Mr. Fischer cited no external funding sources. He had no relevant financial disclosures.
PORTLAND, ORE. – Comorbidities were common in patients with pyoderma gangrenosum (PG), in a single-center retrospective cohort study of 130 patients.
These comorbid diagnoses were not only clinically significant in themselves, but also were associated with changes in treatment efficacy, highlighting the need for holistic surveillance of patients with PG, Alexander Fischer, MPH, said during an oral presentation of his poster at the annual meeting of the Society for Investigative Dermatology. “We should really be screening patients with PG for multiple comorbid conditions,” he emphasized.
The study included patients seen for PG at Johns Hopkins Medicine, Baltimore, between 2006 and 2015. The most common comorbidity was inflammatory bowel disease (35%), followed by hidradenitis suppurativa (14%), rheumatoid arthritis (12%), monoclonal gammopathy (12%), leukemia (2%), and lymphoma (2%). “Interestingly, a substantial proportion of patients had multiple systemic diseases,” Mr. Fischer said. “For example, among our PG patients with rheumatoid arthritis, over a third also had comorbid inflammatory bowel disease. We saw this pattern repeat itself in patients with comorbid hidradenitis suppurativa, and also in patients with comorbid monoclonal gammopathy.”
The researchers used rigorous inclusion and exclusion criteria to verify the diagnosis of PG, said Mr. Fischer, a medical student at Johns Hopkins University, Baltimore, who conducted the analysis under the mentorship of Gerald S. Lazarus, MD, professor of dermatology and medicine at Johns Hopkins Bayview Medical Center. A total of 69% of patients were female, 58% were white, and 35% were black. The average age of PG onset was 47 years. Notably, patients with comorbid hidradenitis suppurativa (HS) had an earlier age of PG onset and were more likely to be black than were patients without comorbid HS, and 53% of young black females with PG onset also had HS.
The investigators explored whether the effect of systemic PG therapies varied in the presence of comorbidities. In a crude analysis of 32 patients who received infliximab (Remicade) for PG, those with comorbid HS were significantly more likely to achieve complete healing of PG wounds (83%) than were those without comorbid HS (31%; P = .03), Mr. Fischer reported. “Our sample size was small for this analysis, but we thought this was an interesting finding that perhaps warrants further investigation,” he said. “We need to do larger longitudinal studies that account for wound characteristics and that include more therapies to get a better grasp of this question.”
Only 57% of patients in this study had their diagnosis confirmed by biopsy, Mr. Fischer noted. However, this study generally resembles others in terms of comorbidity prevalence. For example, a single-center study of 103 patients with PG at Brigham and Women’s Hospital, Boston, found that 34% of patients had comorbid IBD compared with 35% in the Hopkins cohort (Br J Dermatol. 2011 Dec;165[6]:1244-50). In a study of 121 patients with PG at three wound care centers in Germany, 10% of patients had IBD, but 14% had rheumatologic conditions and 7% had blood cancers (J Dtsch Dermatol Ges. 2016 Oct;14[10]:1023-30).
Mr. Fischer cited no external funding sources. He had no relevant financial disclosures.
PORTLAND, ORE. – Comorbidities were common in patients with pyoderma gangrenosum (PG), in a single-center retrospective cohort study of 130 patients.
These comorbid diagnoses were not only clinically significant in themselves, but also were associated with changes in treatment efficacy, highlighting the need for holistic surveillance of patients with PG, Alexander Fischer, MPH, said during an oral presentation of his poster at the annual meeting of the Society for Investigative Dermatology. “We should really be screening patients with PG for multiple comorbid conditions,” he emphasized.
The study included patients seen for PG at Johns Hopkins Medicine, Baltimore, between 2006 and 2015. The most common comorbidity was inflammatory bowel disease (35%), followed by hidradenitis suppurativa (14%), rheumatoid arthritis (12%), monoclonal gammopathy (12%), leukemia (2%), and lymphoma (2%). “Interestingly, a substantial proportion of patients had multiple systemic diseases,” Mr. Fischer said. “For example, among our PG patients with rheumatoid arthritis, over a third also had comorbid inflammatory bowel disease. We saw this pattern repeat itself in patients with comorbid hidradenitis suppurativa, and also in patients with comorbid monoclonal gammopathy.”
The researchers used rigorous inclusion and exclusion criteria to verify the diagnosis of PG, said Mr. Fischer, a medical student at Johns Hopkins University, Baltimore, who conducted the analysis under the mentorship of Gerald S. Lazarus, MD, professor of dermatology and medicine at Johns Hopkins Bayview Medical Center. A total of 69% of patients were female, 58% were white, and 35% were black. The average age of PG onset was 47 years. Notably, patients with comorbid hidradenitis suppurativa (HS) had an earlier age of PG onset and were more likely to be black than were patients without comorbid HS, and 53% of young black females with PG onset also had HS.
The investigators explored whether the effect of systemic PG therapies varied in the presence of comorbidities. In a crude analysis of 32 patients who received infliximab (Remicade) for PG, those with comorbid HS were significantly more likely to achieve complete healing of PG wounds (83%) than were those without comorbid HS (31%; P = .03), Mr. Fischer reported. “Our sample size was small for this analysis, but we thought this was an interesting finding that perhaps warrants further investigation,” he said. “We need to do larger longitudinal studies that account for wound characteristics and that include more therapies to get a better grasp of this question.”
Only 57% of patients in this study had their diagnosis confirmed by biopsy, Mr. Fischer noted. However, this study generally resembles others in terms of comorbidity prevalence. For example, a single-center study of 103 patients with PG at Brigham and Women’s Hospital, Boston, found that 34% of patients had comorbid IBD compared with 35% in the Hopkins cohort (Br J Dermatol. 2011 Dec;165[6]:1244-50). In a study of 121 patients with PG at three wound care centers in Germany, 10% of patients had IBD, but 14% had rheumatologic conditions and 7% had blood cancers (J Dtsch Dermatol Ges. 2016 Oct;14[10]:1023-30).
Mr. Fischer cited no external funding sources. He had no relevant financial disclosures.
AT SID 2017
Key clinical point: Carefully screen for comorbidities when patients have pyoderma gangrenosum (PG).
Major finding: The most common comorbidity was inflammatory bowel disease (35%), followed by hidradenitis suppurativa (14%), rheumatoid arthritis (12%), monoclonal gammopathy (12%), leukemia (2%), and lymphoma (2%).
Data source: A single-center retrospective study of 130 patients seen for pyoderma gangrenosum between 2006 and 2015.
Disclosures: Mr. Fischer cited no external funding sources. He had no relevant financial disclosures.
Targeted treatment does not address RA patients’ mental health
BIRMINGHAM, ENGLAND – Improvements in physical health with response to treatment of rheumatoid arthritis (RA) don’t necessarily translate into improvements in patients’ mental health, based on results of a systematic review presented at the British Society for Rheumatology annual conference.
Reducing levels of joint pain and inflammation did not appreciably improve mental well-being, said Faith Matcham, PhD, of the Institute of Psychiatry, Psychology, and Neuroscience, King’s College London. The standardized mean difference between biologics and disease-modifying antirheumatic drugs (DMARDs) in improving the physical and mental components of the 36-item Short Form survey were a respective 0.47 and 0.25.
A pairwise meta-analysis was performed on 58 and 48 randomized controlled trials, respectively. More than 34,000 patients had been treated in these trials with 28 current or investigational RA therapies, and treatment outcomes were compared with an active, placebo, or usual-care arm. Studies were included if they had assessed any type of mood outcome.
Mental health had been measured in more than half of the RA treatment trials found on the original search, but just 40% of those trials reported mental health outcomes with enough information to be used in the meta-analyses.
Although studies that had compared biologics with placebo accounted for only four studies, none of those showed significant change in mental health outcomes with active therapy.
“Providing effective pharmacotherapy alone is going to be insufficient to produce meaningful improvement in mental health outcomes for the majority,” Dr. Matcham observed. She added that, even after treatment, mental health measures in RA patients remained lower than those in the general population. “It is essential to optimize both mental and physical health care outcomes,” she concluded, and an integrated approach needs to be taken.
Dr. Matcham reported having no financial disclosures.
BIRMINGHAM, ENGLAND – Improvements in physical health with response to treatment of rheumatoid arthritis (RA) don’t necessarily translate into improvements in patients’ mental health, based on results of a systematic review presented at the British Society for Rheumatology annual conference.
Reducing levels of joint pain and inflammation did not appreciably improve mental well-being, said Faith Matcham, PhD, of the Institute of Psychiatry, Psychology, and Neuroscience, King’s College London. The standardized mean difference between biologics and disease-modifying antirheumatic drugs (DMARDs) in improving the physical and mental components of the 36-item Short Form survey were a respective 0.47 and 0.25.
A pairwise meta-analysis was performed on 58 and 48 randomized controlled trials, respectively. More than 34,000 patients had been treated in these trials with 28 current or investigational RA therapies, and treatment outcomes were compared with an active, placebo, or usual-care arm. Studies were included if they had assessed any type of mood outcome.
Mental health had been measured in more than half of the RA treatment trials found on the original search, but just 40% of those trials reported mental health outcomes with enough information to be used in the meta-analyses.
Although studies that had compared biologics with placebo accounted for only four studies, none of those showed significant change in mental health outcomes with active therapy.
“Providing effective pharmacotherapy alone is going to be insufficient to produce meaningful improvement in mental health outcomes for the majority,” Dr. Matcham observed. She added that, even after treatment, mental health measures in RA patients remained lower than those in the general population. “It is essential to optimize both mental and physical health care outcomes,” she concluded, and an integrated approach needs to be taken.
Dr. Matcham reported having no financial disclosures.
BIRMINGHAM, ENGLAND – Improvements in physical health with response to treatment of rheumatoid arthritis (RA) don’t necessarily translate into improvements in patients’ mental health, based on results of a systematic review presented at the British Society for Rheumatology annual conference.
Reducing levels of joint pain and inflammation did not appreciably improve mental well-being, said Faith Matcham, PhD, of the Institute of Psychiatry, Psychology, and Neuroscience, King’s College London. The standardized mean difference between biologics and disease-modifying antirheumatic drugs (DMARDs) in improving the physical and mental components of the 36-item Short Form survey were a respective 0.47 and 0.25.
A pairwise meta-analysis was performed on 58 and 48 randomized controlled trials, respectively. More than 34,000 patients had been treated in these trials with 28 current or investigational RA therapies, and treatment outcomes were compared with an active, placebo, or usual-care arm. Studies were included if they had assessed any type of mood outcome.
Mental health had been measured in more than half of the RA treatment trials found on the original search, but just 40% of those trials reported mental health outcomes with enough information to be used in the meta-analyses.
Although studies that had compared biologics with placebo accounted for only four studies, none of those showed significant change in mental health outcomes with active therapy.
“Providing effective pharmacotherapy alone is going to be insufficient to produce meaningful improvement in mental health outcomes for the majority,” Dr. Matcham observed. She added that, even after treatment, mental health measures in RA patients remained lower than those in the general population. “It is essential to optimize both mental and physical health care outcomes,” she concluded, and an integrated approach needs to be taken.
Dr. Matcham reported having no financial disclosures.
AT RHEUMATOLOGY 2017
Key clinical point: A response to pharmacotherapy per se is not directly related to improved mental health outcomes in patients with rheumatoid arthritis.
Major finding: The standardized mean difference between biologics and DMARDs in improving the physical and mental components of the 36-item Short Form survey were 0.47 and 0.25, respectively.
Data source: A systematic review and meta-analysis of RA treatment trials involving 34,087 patients.
Disclosures: Dr. Matcham reported having no relevant financial disclosures.
Smartphone apps may aid home rheumatoid arthritis monitoring
BIRMINGHAM, ENGLAND – Researchers in the United Kingdom are looking at how smartphone technology can help to improve how patients with rheumatoid arthritis (RA) monitor their disease at home and between clinic visits.
As part of the Remote Monitoring of Rheumatoid Arthritis (REMORA) study, a team led by Will Dixon, MD, at the University of Manchester (England), has developed an app that links directly into electronic patient records to help collect information from patients between their regular clinic visits for both self-monitoring and research purposes.
“REMORA is motivated by the need to learn about what happens to patients in between clinic visits, and that’s both for clinical care and for research but also to have the opportunity to support self-management, so we’ve designed the study to meet those three needs,” Dr. Dixon, professor and chair of digital epidemiology in Manchester University’s division of musculoskeletal and dermatological sciences, said in an interview at the British Society for Rheumatology annual conference.
Dr. Dixon explained that when patients are seen every few months they might forget or underplay events that could have significance for their clinical care. Use of the beta version of the app between clinic consultations in the study proved there was recall error.
“In the consultation, we’d ask people how they’d been doing before looking at the graphs in the app, and even people who had said they’d been absolutely fine since they’d last been seen, even in the previous month of beta-testing, have signs that they could have been [having] pain flares,” Dr. Dixon said. This sort of prospective data collection by the app could enable discussion of any irregularities even if more stoic patients reported having no problems.
The responses showed that there were some similarities in the information that clinicians and researchers and patients want to record, but also some key differences.
All groups wanted the app to be able to collect information about possible changes in disease activity (indicated by levels of pain, joint swelling, or disease flares) and the impact that these had on physical and emotional well-being.
Patients were open to regular monitoring, if not too burdensome, but would prefer to note things down “when something happened.” On the other hand, clinicians and researchers wanted regularity and consistency in the monitoring, although they saw the benefit of a more “ad hoc” approach.
Clinicians and researchers felt no need to “reinvent the wheel” and indicated that existing validated tools could be used to collect the information. Conversely, patients preferred a more pictorial or free-text approach, although were aware of some standardized tools in common use.
Daily, weekly, and monthly question sets were developed, with a diary that uses emojis to indicate how people using the app are feeling and a free-text area to allow them to note down any significant health events or thoughts.
Pilot testing of the app has been done in one hospital so far, but it was so well received that patients did not want to have to stop using it at the end of the study, Dr. Austin said in an interview.
Linking into the patient records is a unique approach, and if it proves successful in RA, it could be rolled out across the country’s National Health Service (NHS) and perhaps even into other chronic conditions where self-monitoring is needed.
“We all know we have a limited time in our consultations, so we need to develop a system whereby a clinician, in the 15 minutes they have got for a follow-up appointment, can set somebody up with an ‘app prescription,’ ” Dr. Dixon said. “We’re looking to really develop a blueprint for how apps can successfully connect into the NHS,” Dr. Dixon said. At present, however, the next step is to try to scale up the app for use in several hospitals within an area rather than roll it out nationally, he said.
Using built-in accelerometer for research
Another approach to harnessing smartphone technology is being taken by researchers at the University of Southampton (England), where engineering postgraduate student Jimmy Caroupapoulle and his collaborators are working on an app that continually uses the built-in sensors in a phone to detect movements, and thus how physically active someone is.
“What we are trying to achieve is to develop an application that can just run in the background so people do not have to do too much,” Mr. Caroupapoulle explained in an interview around his poster presentation.
Using the app, called RApp, patients will be able to answer daily questions based on existing tools (RAPID3 and MDHAQ) to record their levels of pain, joint inflammation, and physical activity. The latter would be recorded via the phone’s onboard accelerometer to give a more objective view of whether the patient is moving around, as well as the patient’s speed in getting up from a seated position. The app collects data using the 28-joint Disease Activity Score so an indication of the severity of joint pain or inflammation can be assessed.
The aim is to give the patients the power to monitor themselves but also to facilitate discussion with their physicians. Data from the app will be integrated into an online portal so that patients and their doctors can see the information provided.
So far, 5 patients with RA have tested the application and the next stage is to release the application to a wider group, perhaps 20 patients, Mr. Caroupapoulle said.
“There are lots of apps out there, but this is something that looks at the quality of movement.” consultant rheumatologist Christopher Edwards, MD, a member of the team behind the RApp, said in an interview.
As opposed to pedometers or other devices that monitor physical activity to varying degrees of accuracy, RApp looks at how people accelerate as they stand up or move, which can be important for those with arthritis, and how that relates to their disease activity, said Dr. Edwards, professor of rheumatology at the University of Southampton.
“You can’t guarantee that someone always had their phone in their hand or in their bag,” Dr. Edwards said, “so what you want to do is get a sample from time during the day that gives you an overall representation, even if that is a very short period, just once during the day, then we’ll see if that makes a difference over time and whether that correlates with someone’s disease activity.”
The REMORA study is sponsored by Arthritis Research UK and the National Institute of Health Research Collaboration for Leadership in Applied Health Research and Care Greater Manchester. RApp is being developed without commercial funding. Dr. Austin, Dr. Dixon, Mr. Caroupapoulle, and Dr. Edwards stated they had no conflicts of interest.
BIRMINGHAM, ENGLAND – Researchers in the United Kingdom are looking at how smartphone technology can help to improve how patients with rheumatoid arthritis (RA) monitor their disease at home and between clinic visits.
As part of the Remote Monitoring of Rheumatoid Arthritis (REMORA) study, a team led by Will Dixon, MD, at the University of Manchester (England), has developed an app that links directly into electronic patient records to help collect information from patients between their regular clinic visits for both self-monitoring and research purposes.
“REMORA is motivated by the need to learn about what happens to patients in between clinic visits, and that’s both for clinical care and for research but also to have the opportunity to support self-management, so we’ve designed the study to meet those three needs,” Dr. Dixon, professor and chair of digital epidemiology in Manchester University’s division of musculoskeletal and dermatological sciences, said in an interview at the British Society for Rheumatology annual conference.
Dr. Dixon explained that when patients are seen every few months they might forget or underplay events that could have significance for their clinical care. Use of the beta version of the app between clinic consultations in the study proved there was recall error.
“In the consultation, we’d ask people how they’d been doing before looking at the graphs in the app, and even people who had said they’d been absolutely fine since they’d last been seen, even in the previous month of beta-testing, have signs that they could have been [having] pain flares,” Dr. Dixon said. This sort of prospective data collection by the app could enable discussion of any irregularities even if more stoic patients reported having no problems.
The responses showed that there were some similarities in the information that clinicians and researchers and patients want to record, but also some key differences.
All groups wanted the app to be able to collect information about possible changes in disease activity (indicated by levels of pain, joint swelling, or disease flares) and the impact that these had on physical and emotional well-being.
Patients were open to regular monitoring, if not too burdensome, but would prefer to note things down “when something happened.” On the other hand, clinicians and researchers wanted regularity and consistency in the monitoring, although they saw the benefit of a more “ad hoc” approach.
Clinicians and researchers felt no need to “reinvent the wheel” and indicated that existing validated tools could be used to collect the information. Conversely, patients preferred a more pictorial or free-text approach, although were aware of some standardized tools in common use.
Daily, weekly, and monthly question sets were developed, with a diary that uses emojis to indicate how people using the app are feeling and a free-text area to allow them to note down any significant health events or thoughts.
Pilot testing of the app has been done in one hospital so far, but it was so well received that patients did not want to have to stop using it at the end of the study, Dr. Austin said in an interview.
Linking into the patient records is a unique approach, and if it proves successful in RA, it could be rolled out across the country’s National Health Service (NHS) and perhaps even into other chronic conditions where self-monitoring is needed.
“We all know we have a limited time in our consultations, so we need to develop a system whereby a clinician, in the 15 minutes they have got for a follow-up appointment, can set somebody up with an ‘app prescription,’ ” Dr. Dixon said. “We’re looking to really develop a blueprint for how apps can successfully connect into the NHS,” Dr. Dixon said. At present, however, the next step is to try to scale up the app for use in several hospitals within an area rather than roll it out nationally, he said.
Using built-in accelerometer for research
Another approach to harnessing smartphone technology is being taken by researchers at the University of Southampton (England), where engineering postgraduate student Jimmy Caroupapoulle and his collaborators are working on an app that continually uses the built-in sensors in a phone to detect movements, and thus how physically active someone is.
“What we are trying to achieve is to develop an application that can just run in the background so people do not have to do too much,” Mr. Caroupapoulle explained in an interview around his poster presentation.
Using the app, called RApp, patients will be able to answer daily questions based on existing tools (RAPID3 and MDHAQ) to record their levels of pain, joint inflammation, and physical activity. The latter would be recorded via the phone’s onboard accelerometer to give a more objective view of whether the patient is moving around, as well as the patient’s speed in getting up from a seated position. The app collects data using the 28-joint Disease Activity Score so an indication of the severity of joint pain or inflammation can be assessed.
The aim is to give the patients the power to monitor themselves but also to facilitate discussion with their physicians. Data from the app will be integrated into an online portal so that patients and their doctors can see the information provided.
So far, 5 patients with RA have tested the application and the next stage is to release the application to a wider group, perhaps 20 patients, Mr. Caroupapoulle said.
“There are lots of apps out there, but this is something that looks at the quality of movement.” consultant rheumatologist Christopher Edwards, MD, a member of the team behind the RApp, said in an interview.
As opposed to pedometers or other devices that monitor physical activity to varying degrees of accuracy, RApp looks at how people accelerate as they stand up or move, which can be important for those with arthritis, and how that relates to their disease activity, said Dr. Edwards, professor of rheumatology at the University of Southampton.
“You can’t guarantee that someone always had their phone in their hand or in their bag,” Dr. Edwards said, “so what you want to do is get a sample from time during the day that gives you an overall representation, even if that is a very short period, just once during the day, then we’ll see if that makes a difference over time and whether that correlates with someone’s disease activity.”
The REMORA study is sponsored by Arthritis Research UK and the National Institute of Health Research Collaboration for Leadership in Applied Health Research and Care Greater Manchester. RApp is being developed without commercial funding. Dr. Austin, Dr. Dixon, Mr. Caroupapoulle, and Dr. Edwards stated they had no conflicts of interest.
BIRMINGHAM, ENGLAND – Researchers in the United Kingdom are looking at how smartphone technology can help to improve how patients with rheumatoid arthritis (RA) monitor their disease at home and between clinic visits.
As part of the Remote Monitoring of Rheumatoid Arthritis (REMORA) study, a team led by Will Dixon, MD, at the University of Manchester (England), has developed an app that links directly into electronic patient records to help collect information from patients between their regular clinic visits for both self-monitoring and research purposes.
“REMORA is motivated by the need to learn about what happens to patients in between clinic visits, and that’s both for clinical care and for research but also to have the opportunity to support self-management, so we’ve designed the study to meet those three needs,” Dr. Dixon, professor and chair of digital epidemiology in Manchester University’s division of musculoskeletal and dermatological sciences, said in an interview at the British Society for Rheumatology annual conference.
Dr. Dixon explained that when patients are seen every few months they might forget or underplay events that could have significance for their clinical care. Use of the beta version of the app between clinic consultations in the study proved there was recall error.
“In the consultation, we’d ask people how they’d been doing before looking at the graphs in the app, and even people who had said they’d been absolutely fine since they’d last been seen, even in the previous month of beta-testing, have signs that they could have been [having] pain flares,” Dr. Dixon said. This sort of prospective data collection by the app could enable discussion of any irregularities even if more stoic patients reported having no problems.
The responses showed that there were some similarities in the information that clinicians and researchers and patients want to record, but also some key differences.
All groups wanted the app to be able to collect information about possible changes in disease activity (indicated by levels of pain, joint swelling, or disease flares) and the impact that these had on physical and emotional well-being.
Patients were open to regular monitoring, if not too burdensome, but would prefer to note things down “when something happened.” On the other hand, clinicians and researchers wanted regularity and consistency in the monitoring, although they saw the benefit of a more “ad hoc” approach.
Clinicians and researchers felt no need to “reinvent the wheel” and indicated that existing validated tools could be used to collect the information. Conversely, patients preferred a more pictorial or free-text approach, although were aware of some standardized tools in common use.
Daily, weekly, and monthly question sets were developed, with a diary that uses emojis to indicate how people using the app are feeling and a free-text area to allow them to note down any significant health events or thoughts.
Pilot testing of the app has been done in one hospital so far, but it was so well received that patients did not want to have to stop using it at the end of the study, Dr. Austin said in an interview.
Linking into the patient records is a unique approach, and if it proves successful in RA, it could be rolled out across the country’s National Health Service (NHS) and perhaps even into other chronic conditions where self-monitoring is needed.
“We all know we have a limited time in our consultations, so we need to develop a system whereby a clinician, in the 15 minutes they have got for a follow-up appointment, can set somebody up with an ‘app prescription,’ ” Dr. Dixon said. “We’re looking to really develop a blueprint for how apps can successfully connect into the NHS,” Dr. Dixon said. At present, however, the next step is to try to scale up the app for use in several hospitals within an area rather than roll it out nationally, he said.
Using built-in accelerometer for research
Another approach to harnessing smartphone technology is being taken by researchers at the University of Southampton (England), where engineering postgraduate student Jimmy Caroupapoulle and his collaborators are working on an app that continually uses the built-in sensors in a phone to detect movements, and thus how physically active someone is.
“What we are trying to achieve is to develop an application that can just run in the background so people do not have to do too much,” Mr. Caroupapoulle explained in an interview around his poster presentation.
Using the app, called RApp, patients will be able to answer daily questions based on existing tools (RAPID3 and MDHAQ) to record their levels of pain, joint inflammation, and physical activity. The latter would be recorded via the phone’s onboard accelerometer to give a more objective view of whether the patient is moving around, as well as the patient’s speed in getting up from a seated position. The app collects data using the 28-joint Disease Activity Score so an indication of the severity of joint pain or inflammation can be assessed.
The aim is to give the patients the power to monitor themselves but also to facilitate discussion with their physicians. Data from the app will be integrated into an online portal so that patients and their doctors can see the information provided.
So far, 5 patients with RA have tested the application and the next stage is to release the application to a wider group, perhaps 20 patients, Mr. Caroupapoulle said.
“There are lots of apps out there, but this is something that looks at the quality of movement.” consultant rheumatologist Christopher Edwards, MD, a member of the team behind the RApp, said in an interview.
As opposed to pedometers or other devices that monitor physical activity to varying degrees of accuracy, RApp looks at how people accelerate as they stand up or move, which can be important for those with arthritis, and how that relates to their disease activity, said Dr. Edwards, professor of rheumatology at the University of Southampton.
“You can’t guarantee that someone always had their phone in their hand or in their bag,” Dr. Edwards said, “so what you want to do is get a sample from time during the day that gives you an overall representation, even if that is a very short period, just once during the day, then we’ll see if that makes a difference over time and whether that correlates with someone’s disease activity.”
The REMORA study is sponsored by Arthritis Research UK and the National Institute of Health Research Collaboration for Leadership in Applied Health Research and Care Greater Manchester. RApp is being developed without commercial funding. Dr. Austin, Dr. Dixon, Mr. Caroupapoulle, and Dr. Edwards stated they had no conflicts of interest.
Opportunistic infection rates are low with biologics
BIRMINGHAM, ENGLAND – Patients being treated with biologics for rheumatoid arthritis have a low risk for developing opportunistic infections, based on a new analysis of data from one of the largest and longest running biologics registers.
Data on 19,162 patients included in the British Society for Rheumatology Biologics Register for Rheumatoid Arthritis (BSRBR-RA) showed that the incidence rate of opportunistic infections was 1.33 cases per 1,000 patient years when using any biologic drug, including anti–tumor necrosis factor (anti-TNF) drugs, rituximab (Rituxan/MabThera), or the interleukin-6 receptor inhibitor tocilizumab (Actemra).
Incidence rates for opportunistic infections appeared to be lowest with tocilizumab at 0.88 per 1,000 patient years, although the duration of follow-up with this drug was the shortest. Rates for anti-TNF drugs as a whole and rituximab were a respective 1.30 and 1.58 per 1,000 patient years.
“Opportunistic infections remain very rare events,” said Dr. Andrew Rutherford, a rheumatology clinical fellow at King’s College London, England.
The potential for serious infections to develop with biologic treatment is well known, and several analyses have already been performed on the BSRBR-RA data, Dr. Rutherford acknowledged at the British Society for Rheumatology annual conference. However, these prior analyses have become somewhat outdated and don’t reflect current practice or the current cohort of patients starting biologic therapy, he said.
“Using the old comparator arm of continuing patients on DMARD [disease-modifying anti-rheumatic drug] therapy isn’t really relevant for us in clinical practice any more,” he said. “I think for the majority of us, when we’re faced with a patient who’s got high disease activity, we are going to start them on a biologic, and the question is ‘Which biologic is safest or most effective?’ as opposed to ‘Should they just remain on DMARDs?’ ”
Patients currently starting biologic treatments who are included in the Register are also less likely to have been treated with steroids and more likely to have been diagnosed with RA for less than 5 years. Then, there are the newer biologics, such as tocilizumab and even more recently the Janus kinase (JAK) inhibitors.
“So, I think, clearly, there is a need to do updated analyses using the BSRBR,” Dr. Rutherford reasoned.
In the current analysis, which covers more than 99,000 patient years of follow-up overall, the primary aim was to estimate the incidence of opportunistic infections other than tuberculosis (TB) by biologic drug class.
Of 106 cases of opportunistic infections seen in patients treated with anti-TNF drugs, most (48%) resulted from herpes zoster, Pneumocystis pneumonia (PCP; 11.3%), or Aspergillus (11.3%).
There were 24 opportunistic infections in patients treated with rituximab, of which PCP (33.3%) or herpes zoster (29%) were the most common causes.
There were just three opportunistic infections in patients treated with tocilizumab, which were all different organisms, Dr. Rutherford reported.
Using anti-TNF therapy as the control, the unadjusted and adjusted hazard ratios for an opportunistic infection were a respective 1.21 and 0.92 for rituximab and 0.60 and 0.28 for tocilizumab. The confidence intervals were wide, however, crossing 1.0 in all comparisons, Dr. Rutherford emphasized.
PCP is rare with all biologics, but the incidence was almost four-times higher (HR, 3.91) with rituximab versus anti-TNF therapy, but the 95% CIs were wide (1.60–9.92) and probably not enough to influence practice.
A secondary analysis also looked at the incidence of TB by biologic drug class, although this was originally excluded from the study design. Not only has it been previously reported on from BSRBR, “guidelines have come into place that have probably changed the rates of TB dramatically over the years,” Dr. Rutherford said, so comparing older and new cohorts of biologic-treated patients might be “a little bit unfair.”
The incidence of TB per 100,000 patient years was 67.8 for all anti-TNF therapies, with a lower rate seen with rituximab (13.2 per 100,000 patient years) than any individual anti-TNF drug (48.9 for etanercept, 75.5 for infliximab, 84.6 for adalimumab, and 99.0 for certolizumab per 100,000 patient years).
These rates might potentially influence the choice of drug for a patient with a high-risk for reactivation of TB, Dr. Rutherford suggested.
Overall, rates of TB have fallen year over year in the Register. However, that likely reflects better screening and treatment of the infection, he added.
The BSRBR-RA is funded by the BSR through restricted grants from UK pharmaceutical companies. Past and present participating companies include Abbvie, Celltrion, Hospira, Pfizer, UCB, Roche, Merck and Samsung. Dr. Rutherford had no conflicts of interest.
BIRMINGHAM, ENGLAND – Patients being treated with biologics for rheumatoid arthritis have a low risk for developing opportunistic infections, based on a new analysis of data from one of the largest and longest running biologics registers.
Data on 19,162 patients included in the British Society for Rheumatology Biologics Register for Rheumatoid Arthritis (BSRBR-RA) showed that the incidence rate of opportunistic infections was 1.33 cases per 1,000 patient years when using any biologic drug, including anti–tumor necrosis factor (anti-TNF) drugs, rituximab (Rituxan/MabThera), or the interleukin-6 receptor inhibitor tocilizumab (Actemra).
Incidence rates for opportunistic infections appeared to be lowest with tocilizumab at 0.88 per 1,000 patient years, although the duration of follow-up with this drug was the shortest. Rates for anti-TNF drugs as a whole and rituximab were a respective 1.30 and 1.58 per 1,000 patient years.
“Opportunistic infections remain very rare events,” said Dr. Andrew Rutherford, a rheumatology clinical fellow at King’s College London, England.
The potential for serious infections to develop with biologic treatment is well known, and several analyses have already been performed on the BSRBR-RA data, Dr. Rutherford acknowledged at the British Society for Rheumatology annual conference. However, these prior analyses have become somewhat outdated and don’t reflect current practice or the current cohort of patients starting biologic therapy, he said.
“Using the old comparator arm of continuing patients on DMARD [disease-modifying anti-rheumatic drug] therapy isn’t really relevant for us in clinical practice any more,” he said. “I think for the majority of us, when we’re faced with a patient who’s got high disease activity, we are going to start them on a biologic, and the question is ‘Which biologic is safest or most effective?’ as opposed to ‘Should they just remain on DMARDs?’ ”
Patients currently starting biologic treatments who are included in the Register are also less likely to have been treated with steroids and more likely to have been diagnosed with RA for less than 5 years. Then, there are the newer biologics, such as tocilizumab and even more recently the Janus kinase (JAK) inhibitors.
“So, I think, clearly, there is a need to do updated analyses using the BSRBR,” Dr. Rutherford reasoned.
In the current analysis, which covers more than 99,000 patient years of follow-up overall, the primary aim was to estimate the incidence of opportunistic infections other than tuberculosis (TB) by biologic drug class.
Of 106 cases of opportunistic infections seen in patients treated with anti-TNF drugs, most (48%) resulted from herpes zoster, Pneumocystis pneumonia (PCP; 11.3%), or Aspergillus (11.3%).
There were 24 opportunistic infections in patients treated with rituximab, of which PCP (33.3%) or herpes zoster (29%) were the most common causes.
There were just three opportunistic infections in patients treated with tocilizumab, which were all different organisms, Dr. Rutherford reported.
Using anti-TNF therapy as the control, the unadjusted and adjusted hazard ratios for an opportunistic infection were a respective 1.21 and 0.92 for rituximab and 0.60 and 0.28 for tocilizumab. The confidence intervals were wide, however, crossing 1.0 in all comparisons, Dr. Rutherford emphasized.
PCP is rare with all biologics, but the incidence was almost four-times higher (HR, 3.91) with rituximab versus anti-TNF therapy, but the 95% CIs were wide (1.60–9.92) and probably not enough to influence practice.
A secondary analysis also looked at the incidence of TB by biologic drug class, although this was originally excluded from the study design. Not only has it been previously reported on from BSRBR, “guidelines have come into place that have probably changed the rates of TB dramatically over the years,” Dr. Rutherford said, so comparing older and new cohorts of biologic-treated patients might be “a little bit unfair.”
The incidence of TB per 100,000 patient years was 67.8 for all anti-TNF therapies, with a lower rate seen with rituximab (13.2 per 100,000 patient years) than any individual anti-TNF drug (48.9 for etanercept, 75.5 for infliximab, 84.6 for adalimumab, and 99.0 for certolizumab per 100,000 patient years).
These rates might potentially influence the choice of drug for a patient with a high-risk for reactivation of TB, Dr. Rutherford suggested.
Overall, rates of TB have fallen year over year in the Register. However, that likely reflects better screening and treatment of the infection, he added.
The BSRBR-RA is funded by the BSR through restricted grants from UK pharmaceutical companies. Past and present participating companies include Abbvie, Celltrion, Hospira, Pfizer, UCB, Roche, Merck and Samsung. Dr. Rutherford had no conflicts of interest.
BIRMINGHAM, ENGLAND – Patients being treated with biologics for rheumatoid arthritis have a low risk for developing opportunistic infections, based on a new analysis of data from one of the largest and longest running biologics registers.
Data on 19,162 patients included in the British Society for Rheumatology Biologics Register for Rheumatoid Arthritis (BSRBR-RA) showed that the incidence rate of opportunistic infections was 1.33 cases per 1,000 patient years when using any biologic drug, including anti–tumor necrosis factor (anti-TNF) drugs, rituximab (Rituxan/MabThera), or the interleukin-6 receptor inhibitor tocilizumab (Actemra).
Incidence rates for opportunistic infections appeared to be lowest with tocilizumab at 0.88 per 1,000 patient years, although the duration of follow-up with this drug was the shortest. Rates for anti-TNF drugs as a whole and rituximab were a respective 1.30 and 1.58 per 1,000 patient years.
“Opportunistic infections remain very rare events,” said Dr. Andrew Rutherford, a rheumatology clinical fellow at King’s College London, England.
The potential for serious infections to develop with biologic treatment is well known, and several analyses have already been performed on the BSRBR-RA data, Dr. Rutherford acknowledged at the British Society for Rheumatology annual conference. However, these prior analyses have become somewhat outdated and don’t reflect current practice or the current cohort of patients starting biologic therapy, he said.
“Using the old comparator arm of continuing patients on DMARD [disease-modifying anti-rheumatic drug] therapy isn’t really relevant for us in clinical practice any more,” he said. “I think for the majority of us, when we’re faced with a patient who’s got high disease activity, we are going to start them on a biologic, and the question is ‘Which biologic is safest or most effective?’ as opposed to ‘Should they just remain on DMARDs?’ ”
Patients currently starting biologic treatments who are included in the Register are also less likely to have been treated with steroids and more likely to have been diagnosed with RA for less than 5 years. Then, there are the newer biologics, such as tocilizumab and even more recently the Janus kinase (JAK) inhibitors.
“So, I think, clearly, there is a need to do updated analyses using the BSRBR,” Dr. Rutherford reasoned.
In the current analysis, which covers more than 99,000 patient years of follow-up overall, the primary aim was to estimate the incidence of opportunistic infections other than tuberculosis (TB) by biologic drug class.
Of 106 cases of opportunistic infections seen in patients treated with anti-TNF drugs, most (48%) resulted from herpes zoster, Pneumocystis pneumonia (PCP; 11.3%), or Aspergillus (11.3%).
There were 24 opportunistic infections in patients treated with rituximab, of which PCP (33.3%) or herpes zoster (29%) were the most common causes.
There were just three opportunistic infections in patients treated with tocilizumab, which were all different organisms, Dr. Rutherford reported.
Using anti-TNF therapy as the control, the unadjusted and adjusted hazard ratios for an opportunistic infection were a respective 1.21 and 0.92 for rituximab and 0.60 and 0.28 for tocilizumab. The confidence intervals were wide, however, crossing 1.0 in all comparisons, Dr. Rutherford emphasized.
PCP is rare with all biologics, but the incidence was almost four-times higher (HR, 3.91) with rituximab versus anti-TNF therapy, but the 95% CIs were wide (1.60–9.92) and probably not enough to influence practice.
A secondary analysis also looked at the incidence of TB by biologic drug class, although this was originally excluded from the study design. Not only has it been previously reported on from BSRBR, “guidelines have come into place that have probably changed the rates of TB dramatically over the years,” Dr. Rutherford said, so comparing older and new cohorts of biologic-treated patients might be “a little bit unfair.”
The incidence of TB per 100,000 patient years was 67.8 for all anti-TNF therapies, with a lower rate seen with rituximab (13.2 per 100,000 patient years) than any individual anti-TNF drug (48.9 for etanercept, 75.5 for infliximab, 84.6 for adalimumab, and 99.0 for certolizumab per 100,000 patient years).
These rates might potentially influence the choice of drug for a patient with a high-risk for reactivation of TB, Dr. Rutherford suggested.
Overall, rates of TB have fallen year over year in the Register. However, that likely reflects better screening and treatment of the infection, he added.
The BSRBR-RA is funded by the BSR through restricted grants from UK pharmaceutical companies. Past and present participating companies include Abbvie, Celltrion, Hospira, Pfizer, UCB, Roche, Merck and Samsung. Dr. Rutherford had no conflicts of interest.
AT RHEUMATOLOGY 2017
Key clinical point: Opportunistic infections rarely occur in patients being treated with biologic drugs for rheumatoid arthritis.
Major finding: The unadjusted rate for opportunistic infections was 1.33 per 1000 patient years for all biologics.
Data source: 19,162 patient records held within the British Society for Rheumatology Biologics Register for Rheumatoid Arthritis (BSRBR-RA).
Disclosures: The BSRBR-RA is funded by the BSR through restricted grants from UK pharmaceutical companies. Past and present participating companies include Abbvie, Celltrion, Hospira, Pfizer, UCB, Roche, Merck and Samsung. Dr. Rutherford did not provide disclosures.
Flu shots may spark immune adverse events in PD-1 blockade for NSCLC
GENEVA – The influenza vaccine may interact with immune checkpoint inhibitors in patients with lung cancer, results of a small study suggest.
Among 23 patients with non–small cell lung cancer (NSCLC) treated with a drug targeted against programmed death-1 (PD-1), the seasonal flu vaccine appeared to produce good serologic protection against infection, but at the possible cost of an increase in the rate of immune-related adverse events (IrAE), reported Sacha Rothschild, MD, PhD, of University Hospital Basel (Switzerland) at the European Lung Cancer Conference.
Among 23 patients with lung cancer treated with a PD-1 inhibitor, 12 (52.2%) had one or more IrAEs. In contrast, the most frequent IrAE in a key registration trial for nivolumab (Opdivo) was skin rash, which occurred in 9% of patients (N Engl J Med. 2015 Jul 9;373:1627-39).
“It’s a very small study, but it raises some concern that there might be an interaction between the vaccine and PD-1 blockade,” Dr. Rothschild said.
To see whether blocking the PD-1/PD–ligand-1 (PD-L1) axis might induce an overactive immune response, the investigators prospectively studied 23 patients with NSCLC who were undergoing treatment with a PD-1 inhibitor – 22 with nivolumab and 1 with pembrolizumab (Keytruda) – who were also vaccinated with a trivalent influenza vaccine in October or November 2015. They used the partners of the patients, also vaccinated, for an age-matched cohort of healthy controls.
The investigators looked at antibody titers against flu strains covered by the vaccine, measured inflammatory chemokines and assessed the vaccine’s safety and the frequency of IrAEs.
None of the patients came down with the flu during the 2015-2016 season. There were no major differences over time in the generation of antibodies against all three viral strains tested.
However, at both 30 and 60 days after vaccination, a hemagglutination inhibition assay showed slightly elevated antibody titers among patients, compared with controls. Antibody titers against H1N1 virus also appeared to increase somewhat more rapidly among patients than among controls, the authors found.
The patients appeared to tolerate the vaccine well, and no serious adverse events were reported within 30 days of vaccination.
When they looked at the incidence of IrAEs, however, the investigators found that six patients had grade 1 or 2 IrAEs, and six had grade 3 or 4 events.
The events included skin rash and arthritis in three patients each, colitis and encephalitis in two patients each, and hypothyroidism, pneumonitis, and neuropathy in one patient each.
“We looked into inflammatory chemokines to understand if there was a high rate of systemic inflammation, and we didn’t find any differences in this regard. So far, we have no clue about why the immune-related adverse event rate in this group is higher,” Dr. Rothschild said.
Although the sample size was small, the IrAE effect they saw was large enough to warrant concern, and it should be studied in a larger population sample, he said.
Egbert Smit, MD, PhD, of the Netherlands Cancer Institute in Amsterdam, who was not involved in the study, commented that “it shows how much we still have to learn about the optimal use of checkpoint inhibitors in lung cancer patients. The study is important as it is the first to investigate the impact of influenza vaccination in such patients, and there is a hint that we actually put them at increased risk for serious toxicities, including encephalitis. However, until we have data on a larger cohort, preferably in a controlled, prospective study, in my institution, we advocate influenza vaccination irrespective of concurrent treatment with immune-checkpoint inhibitors.”
The study was supported by institutional funding. The investigators and Dr. Smit reported no relevant conflicts of interest.
GENEVA – The influenza vaccine may interact with immune checkpoint inhibitors in patients with lung cancer, results of a small study suggest.
Among 23 patients with non–small cell lung cancer (NSCLC) treated with a drug targeted against programmed death-1 (PD-1), the seasonal flu vaccine appeared to produce good serologic protection against infection, but at the possible cost of an increase in the rate of immune-related adverse events (IrAE), reported Sacha Rothschild, MD, PhD, of University Hospital Basel (Switzerland) at the European Lung Cancer Conference.
Among 23 patients with lung cancer treated with a PD-1 inhibitor, 12 (52.2%) had one or more IrAEs. In contrast, the most frequent IrAE in a key registration trial for nivolumab (Opdivo) was skin rash, which occurred in 9% of patients (N Engl J Med. 2015 Jul 9;373:1627-39).
“It’s a very small study, but it raises some concern that there might be an interaction between the vaccine and PD-1 blockade,” Dr. Rothschild said.
To see whether blocking the PD-1/PD–ligand-1 (PD-L1) axis might induce an overactive immune response, the investigators prospectively studied 23 patients with NSCLC who were undergoing treatment with a PD-1 inhibitor – 22 with nivolumab and 1 with pembrolizumab (Keytruda) – who were also vaccinated with a trivalent influenza vaccine in October or November 2015. They used the partners of the patients, also vaccinated, for an age-matched cohort of healthy controls.
The investigators looked at antibody titers against flu strains covered by the vaccine, measured inflammatory chemokines and assessed the vaccine’s safety and the frequency of IrAEs.
None of the patients came down with the flu during the 2015-2016 season. There were no major differences over time in the generation of antibodies against all three viral strains tested.
However, at both 30 and 60 days after vaccination, a hemagglutination inhibition assay showed slightly elevated antibody titers among patients, compared with controls. Antibody titers against H1N1 virus also appeared to increase somewhat more rapidly among patients than among controls, the authors found.
The patients appeared to tolerate the vaccine well, and no serious adverse events were reported within 30 days of vaccination.
When they looked at the incidence of IrAEs, however, the investigators found that six patients had grade 1 or 2 IrAEs, and six had grade 3 or 4 events.
The events included skin rash and arthritis in three patients each, colitis and encephalitis in two patients each, and hypothyroidism, pneumonitis, and neuropathy in one patient each.
“We looked into inflammatory chemokines to understand if there was a high rate of systemic inflammation, and we didn’t find any differences in this regard. So far, we have no clue about why the immune-related adverse event rate in this group is higher,” Dr. Rothschild said.
Although the sample size was small, the IrAE effect they saw was large enough to warrant concern, and it should be studied in a larger population sample, he said.
Egbert Smit, MD, PhD, of the Netherlands Cancer Institute in Amsterdam, who was not involved in the study, commented that “it shows how much we still have to learn about the optimal use of checkpoint inhibitors in lung cancer patients. The study is important as it is the first to investigate the impact of influenza vaccination in such patients, and there is a hint that we actually put them at increased risk for serious toxicities, including encephalitis. However, until we have data on a larger cohort, preferably in a controlled, prospective study, in my institution, we advocate influenza vaccination irrespective of concurrent treatment with immune-checkpoint inhibitors.”
The study was supported by institutional funding. The investigators and Dr. Smit reported no relevant conflicts of interest.
GENEVA – The influenza vaccine may interact with immune checkpoint inhibitors in patients with lung cancer, results of a small study suggest.
Among 23 patients with non–small cell lung cancer (NSCLC) treated with a drug targeted against programmed death-1 (PD-1), the seasonal flu vaccine appeared to produce good serologic protection against infection, but at the possible cost of an increase in the rate of immune-related adverse events (IrAE), reported Sacha Rothschild, MD, PhD, of University Hospital Basel (Switzerland) at the European Lung Cancer Conference.
Among 23 patients with lung cancer treated with a PD-1 inhibitor, 12 (52.2%) had one or more IrAEs. In contrast, the most frequent IrAE in a key registration trial for nivolumab (Opdivo) was skin rash, which occurred in 9% of patients (N Engl J Med. 2015 Jul 9;373:1627-39).
“It’s a very small study, but it raises some concern that there might be an interaction between the vaccine and PD-1 blockade,” Dr. Rothschild said.
To see whether blocking the PD-1/PD–ligand-1 (PD-L1) axis might induce an overactive immune response, the investigators prospectively studied 23 patients with NSCLC who were undergoing treatment with a PD-1 inhibitor – 22 with nivolumab and 1 with pembrolizumab (Keytruda) – who were also vaccinated with a trivalent influenza vaccine in October or November 2015. They used the partners of the patients, also vaccinated, for an age-matched cohort of healthy controls.
The investigators looked at antibody titers against flu strains covered by the vaccine, measured inflammatory chemokines and assessed the vaccine’s safety and the frequency of IrAEs.
None of the patients came down with the flu during the 2015-2016 season. There were no major differences over time in the generation of antibodies against all three viral strains tested.
However, at both 30 and 60 days after vaccination, a hemagglutination inhibition assay showed slightly elevated antibody titers among patients, compared with controls. Antibody titers against H1N1 virus also appeared to increase somewhat more rapidly among patients than among controls, the authors found.
The patients appeared to tolerate the vaccine well, and no serious adverse events were reported within 30 days of vaccination.
When they looked at the incidence of IrAEs, however, the investigators found that six patients had grade 1 or 2 IrAEs, and six had grade 3 or 4 events.
The events included skin rash and arthritis in three patients each, colitis and encephalitis in two patients each, and hypothyroidism, pneumonitis, and neuropathy in one patient each.
“We looked into inflammatory chemokines to understand if there was a high rate of systemic inflammation, and we didn’t find any differences in this regard. So far, we have no clue about why the immune-related adverse event rate in this group is higher,” Dr. Rothschild said.
Although the sample size was small, the IrAE effect they saw was large enough to warrant concern, and it should be studied in a larger population sample, he said.
Egbert Smit, MD, PhD, of the Netherlands Cancer Institute in Amsterdam, who was not involved in the study, commented that “it shows how much we still have to learn about the optimal use of checkpoint inhibitors in lung cancer patients. The study is important as it is the first to investigate the impact of influenza vaccination in such patients, and there is a hint that we actually put them at increased risk for serious toxicities, including encephalitis. However, until we have data on a larger cohort, preferably in a controlled, prospective study, in my institution, we advocate influenza vaccination irrespective of concurrent treatment with immune-checkpoint inhibitors.”
The study was supported by institutional funding. The investigators and Dr. Smit reported no relevant conflicts of interest.
AT ELCC
Key clinical point:
Major finding: Of 23 patients who were vaccinated, 12 developed IrAEs, including 6 grade 1/2 and 6 grade 3/4 events.
Data source: Prospective study of 23 patients with NSCLC and 23 healthy controls.
Disclosures: The study was supported by institutional funding. The investigators reported no relevant conflicts of interest.